FDA.reportPublic FDA data

Primrose Medical, Inc

Primary DI
00852323007101
Brand
Primrose Medical, Inc
Company
Primrose Medical Inc
Model
900-5088
Device description
Sub-Q ( subcutaneous ) Administration set, Safety
Published
2022-10-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FPASet, Administration, Intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K920537000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K920537000SUBCUTANEOUS INFUSION SETMarquette Medical, Inc.1992-10-13FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852323007101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852323007101008523230071018523230071010852323007101

GMDN Terms#

Term, Definition table
TermDefinition
Subcutaneous infusion/injection port needleA sterile, sharp bevel-edged, hollow tubular metal instrument intended to be attached to a syringe and designed for the therapeutic injection or infusion of medicinal substances directly beneath the skin layer. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
617604392
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852323007002Primrose Medical, Inc900-50762022-10-25
00852323007019Primrose Medical, Inc.900-50772022-10-25
00852323007026Primrose Medical, Inc900-50782022-10-25
00852323007033Primrose Medical, Inc900-50792022-10-25
00852323007040Primrose Medical, Inc900-50802022-10-25
00852323007057Primrose Medical, Inc900-50812022-10-25
00852323007064Primrose Medical, Inc900-50822022-10-25
00852323007071Primrose Medical, Inc900-50832022-10-25
00852323007088Primrose Medical, Inc900-50842022-10-25
00852323007095Primrose Medical, Inc900-50852022-10-25
00852323007118Primrose Medical, Inc900-50892022-10-25
00852323007125Primrose Medical, Inc900-50922022-10-25
00852323007132Primrose Medical, Inc900-50932022-10-25
00852323007149Primrose Medical, Inc900-50942022-10-25
00852323007156Primrose Medical, Inc900-50952022-10-25
00852323007163Primrose Medical, Inc900-50962022-10-25
00852323007170Primrose Medical, Inc900-50982022-10-25
00852323007187Primrose Medical, Inc900-50992022-10-25
00852323007194Primrose Medical, Inc900-51002022-10-25
00852323007200Primrose Medical, Inc900-51012022-10-25

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